1. Field of the Invention
The present invention relates to hypodermic needles used for injecting drugs into parenteral vials and/or removing the contents after mixing. Air venting of these vials is provided with this apparatus. Needles used with syringes are found in the general class of "Surgery." Withdrawal of the fluid contents from vials creates negative pressure problems and this invention is directed to providing venting of a vial.
Venting of the stoppered vial is desirable and necessary because of the noted negative pressures developed as and while the fluid is withdrawn from the vial. Constant and continued venting of the vial eliminates this problem of negative pressure. Drawbacks are present in commonly-used and -known procedures. In a procedure using two needle punctures, every time a vial is punctured there is a risk of contamination; it is evident that the fewer times a container needs to be punctured, the more aseptic the interior. It is also to be noted that this procedure is a very clumsy procedure as the vial must be held while securing two needles and syringe which are attached thereto. This procedure requires much manipulation.
2. Description of the Prior Art
Heretofore, small volume parenteral fluid containers have been pierced with hypodermic needles connected to syringes to inject fluid for reconstitution. After reconstitution the parenteral vial is repunctured and the contents removed. Alternately, a hypodermic needle-syringe combination is left within the vial while it is shaken and then the mixed drug is removed. Unfortunately, in this system the parenteral vial becomes pressurized during the procedure. As a result, a condition can and does occur, which is known as "blowback," in which particles of drug are blown into the air. This "blowback" can be very harmful to the personnel preparing such drugs. These hazards are well documented. To overcome these hazards, it is recommended that the reconstituting vial be vented at all times.
A careful pre-Ex search was made in the known art and in art which might indicate the construction of the suction needle apparatus of this invention. Swaging of two tubular members is very common and well known. Swaging is usually used for joining or connecting like size tubing extents. For the purpose of effecting such joining, an end is expanded sufficiently to provide nesting. Patents showing this procedure are U.S. Pat. No. 1,703,037 to Heck, as issued Feb. 19, 1929, and U.S. Pat. No. 4,114,930 to Perkins et al., as issued Sept. 19, 1978. In addition to the above cross-referenced applications of the present inventor, attention is directed to U.S. Pat. No. 3,903,887 to Antoshkiw, as issued Sept. 9, 1974. Also of note is U.S. Pat. No. 3,527,025 to Kinne, as issued Sept. 8, 1970, which shows using indenting apparatus which, as shown, bends the interior wire. An intending tool is shown in U.S. Pat. No. 3,332,272 to Tonchen, as issued July 25, 1967. As shown, a conduit and coupling are secured by the indenting tool. A very recently issued U.S. Pat. No. 4,505,709, as issued to Froning et al., on Mar. 19, 1985, is also noted, but this device requires two needles arrayed side by side and a special hub device which carries the needles as separate members and still requires the syringe to have an additional conduit. The present invention is much less elaborate. Also of note in U.S. Pat. No. 3,599,637 to Schwartz, as issued Aug. 17, 1971, and shows the use of flexible tubing with a penetrating needle. This needle is designed to be removable from the flexible tubing. As far as is known, it is novel to provide the concept of a suction needle using a stainless steel needle conventionally secured to a syringe hub while providing and using a second and larger sleeve cannula as a vent conduit and securing this second sleeve or cannula with crimping means so that the sleeve tightly engages the first needle while not altering the function or size of the first needle and vent conduit.